Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome

NCT05001997 | Unknown

• 1 other identifier: HEALTH 0158
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder defined by recurrent abdominal pain, bloating, abdominal distention and altered bowel habits. IBS is common among athletes and can impair performance. IBS was found to be prevalent in 9.8% (n=430) of endurance athletes. The condition is associated with significantly reduced quality of life. IBS patients often attribute their gastrointestinal effects to lactose intolerance (LI) and may avoid/limit intake of dairy products. As LI and IBS share similar symptoms, IBS patients may wrongly attribute lactose intolerance as one of the causative factors and avoid dairy products altogether. Self-imposed reductions in consumption of dairy products could reduce calcium intake leading to reduced bone mineral density. This study aims to determine the prevalence of lactose malabsorption among athletes suffering from IBS and the potential of lactose free probiotics dairy products in alleviating gastrointestinal symptoms. The inclusion of probiotics dairy products in patients' diet will be beneficial in the long term to ensure adequate intake of calcium.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• IBS Severity Score Scale (IBS-SSS)

  The IBS-SSS is a questionnaire commonly used to evaluate the severity of IBS symptoms. There are five questions (i) abdominal pain intensity; (ii) abdominal distension; (iii) bowel habit dissatisfaction, (iv) life interference and (v) abdominal pain frequency (defined as number of days with pain during the last 10 days). Higher scores indicate more severe symptoms.

  3 weeks

Secondary Outcomes (2)

• IBS Quality of Life (IBS-QOL)

  3 weeks

• Stool frequency and consistency

  3 weeks

Study Arms (2)

Diet A - Lactose free probiotic yogurt

ACTIVE COMPARATOR

Plain flavoured lactose free probiotic yogurt (contains Lactobacillus acidophilus and Bifidobacterium lactis)

Dietary Supplement: Lactose free probiotic yogurt

Diet B - Lactose free yogurt (non-probiotic)

PLACEBO COMPARATOR

Plain flavoured lactose free yogurt (contains only starter cultures)

Dietary Supplement: Lactose free probiotic yogurt

Interventions

Lactose free probiotic yogurt DIETARY_SUPPLEMENT

Probiotics are non-pathogenic, live microbes that when eaten or administered In adequate amount, it confer health benefits to host. Only lactose free probiotic yogurt containing cultures such as Lactobacillus acidophilus and Bifidobacterium lactis will be selected.

Diet A - Lactose free probiotic yogurt; Diet B - Lactose free yogurt (non-probiotic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recreational athlete (defined as a person who is physically active but does not train for competition at the same level of intensity and focus as a competitive athlete )
• Diagnosed with irritable bowel syndrome

You may not qualify if:

• Other gastrointestinal diseases such as inflammatory bowel disease, other serious chronic diseases, coeliac disease, have an allergy to product ingredients (milk), diabetic and pregnant or breastfeeding.
• unable to fast overnight, undergoing antibiotic therapies, bowel preparation for investigative procedures, and change to IBS medication during the past month prior to data collection.

Sponsors & Collaborators

• University of Central Lancashire: lead

Study Sites (1)

University of Central Lancashire

Preston, PR1 2HE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Jan Soon

CONTACT

+441772201201; jmsoon@uclan.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All yogurt labels will be covered or masked with corrugated sleeves
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Single-blinded, randomised crossover study

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 12, 2021
• Study Start: September 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)